Desenex Spray

Generic Name: tolnaftate topical (toll NAF tate)

Brand Names: Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Blis-To-Sol, Desenex Spray, Fungatin, Fungi-Guard, Genaspor, Hongos, NP 27, Podactin, T-Athlete, Tinactin, Tinaspore, Ting

What is Desenex Spray (tolnaftate topical)?

Tolnaftate topical is an antifungal medication. Tolnaftate topical prevents fungus from growing on the skin.

Tolnaftate topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. Tolnaftate is also used, along with other antifungals, to treat infections of the nails, scalp, palms, and soles of the feet. The powder and powder aerosol may be used to prevent athlete's foot.

Tolnaftate topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Desenex Spray (tolnaftate topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Desenex Spray (tolnaftate topical)?

Do not use tolnaftate topical if you have had an allergic reaction to it in the past.

It is not known whether tolnaftate topical will be harmful to an unborn baby. Do not use tolnaftate topical without first talking to your doctor if you are pregnant. It is not known whether tolnaftate topical passes into breast milk. Do not use tolnaftate topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Desenex Spray (tolnaftate topical)?

Use tolnaftate topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the gel, cream, lotion, spray, or powder twice daily as directed for 2 to 6 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 10 days or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in the eyes, nose, or mouth. Store tolnaftate topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of tolnaftate topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of tolnaftate topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that tolnaftate topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Desenex Spray (tolnaftate topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Desenex Spray (tolnaftate topical) side effects

Serious side effects of tolnaftate topical use are not expected to occur. Stop using tolnaftate topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Desenex Spray (tolnaftate topical)?

Other skin medications may affect the absorption or effectiveness of tolnaftate topical. Avoid using other topicals at the same time except under the direction of a doctor.

More Desenex Spray resources

• Desenex Spray Side Effects (in more detail)
• Desenex Spray Use in Pregnancy & Breastfeeding
• 0 Reviews for Desenex - Add your own review/rating

• Desenex Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Absorbine Jr. Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Blis-To-Sol Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Tinactin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Desenex Spray with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about tolnaftate topical written for health professionals that you may read.

See also: Desenex side effects (in more detail)

Dilatrate-SR

isosorbide dinitrate

Dosage Form: sustained release capsules

Description

Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5 dinitrate, an organic nitrate whose structural formula is

and whose molecular weight is 236.14. The organic nitrates are vasodilators, active on both arteries and veins. Each dilatrate®-SR sustained release capsule contains 40 mg of isosorbide dinitrate, in a microdialysis delivery system that causes the active drug to be released over an extended period. Each capsule also contains ethylcellulose, lactose, pharmaceutical glaze, starch, sucrose and talc. The capsule shells contain D&C Red 33, D&C Yellow 10, gelatin and titanium dioxide.

Clinical Pharmacology

The principal pharmacological action of isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.

Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were no more effective than placebo after 24 hours (or less) of continuous therapy. Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their antianginal efficacy been restored.

Pharmacokinetics

The kinetics of absorption of isosorbide dinitrate from dilatrate®-SR sustained release capsules have not been well studied. Studies of immediate-release formulations of ISDN have found highly variable bioavailability (10 to 90%), with extensive first-pass metabolism in the liver. Most such studies have observed progressive increases in bioavailability during chronic therapy; it is not known whether similar increases in bioavailability appear during the course of chronic therapy with dilatrate®-SR sustained release capsules.

Once absorbed, the distribution volume of isosorbide dinitrate is 2-4 L/kg and this volume is cleared at the rate of 2-4 L/min, so ISDN’s half-life in serum is about an hour. Since the clearance exceeds hepatic blood flow, considerable extrahepatic metabolism must also occur. Clearance is affected primarily by denitration to the 2-mononitrate (15 to 25%) and the

5-mononitrate (75 to 85%).

Both metabolites have biological activity, especially the 5-mononitrate. With an overall half-life of about 5 hours, the 5-mononitrate is cleared from the serum by denitration to isosorbide; glucuronidation to the 5-mononitrate glucuronide; and denitration/hydration to sorbitol. The

2-mononitrate has been less well studied, but it appears to participate in the same metabolic pathways with a half-life of about 2 hours.

The interdosing interval sufficient to avoid tolerance to avoid tolerance to ISDN has not been well defined. Studies of nitroglycerin (an organic nitrate with a very short half-life) have shown that dosing intervals of 10-12 hours are usually sufficient to prevent or attenuate tolerance. Dosing intervals that have succeeded in avoiding tolerance during trials of moderate doses

(e.g., 30 mg) of immediate release ISDN have generally been somewhat longer (at least

14 hours), but this is consistent with the longer half-lives of ISDN and its active metabolites.

An interdosing interval sufficient to avoid tolerance with dilatrate®-SR has not been demonstrated. In an eccentric dosing study, 40 mg capsules of dilatrate®-SR were administered daily at 0800 and 1400 hours. After two weeks of this regimen, dilatrate®-SR was statistically indistinguishable from placebo. Thus, the necessary interdosing interval sufficient to avoid tolerance remains unknown, but it must be greater than 18 hours.

Few well-controlled clinical trials of organic nitrates have been designed to detect rebound or withdrawal effects. In one such trial, however, subjects receiving nitroglycerin had less exercise tolerance at the end of the daily interdosing interval than the parallel group receiving placebo. The incidence, magnitude, and clinical significance of similar phenomena in patients receiving ISDN have not been studied.

Clinical trials

In clinical trials, extended-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 40 to 160 mg. A controlled trial using a single

40 mg sustained release oral dose of isosorbide dinitrate (dilatrate®-SR) has demonstrated effective reductions in exercise-related angina for up to 8 hours. Antianginal activity is present about 1 hour after dosing.

Adequate multiple-dose trials of dilatrate®-SR sustained release capsules have not been reported.

Most controlled trials of multiple-dose immediate-release oral ISDN taken every 12 hours (or more frequently) for several weeks have shown statistically significant antianginal efficacy for only 2 hours after dosing. Once-daily regimens, and regimens with one daily interdosing interval of at least 14 hours (e.g., a regimen providing doses at 0800, 1400 and 1800 hours), have shown efficacy after the first dose of each day that was similar to that shown in the single dose studies cited above. The efficacy of subsequent doses has not been demonstrated. From large, well-controlled studies of other nitrates, it is reasonable to believe that the maximal achievable daily duration of antianginal effect from isosorbide dinitrate is about 12 hours. No dosing regimen for dilatrate®-SR sustained release capsules has actually been shown to achieve this duration of effect.

Indications and Usage

dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Contraindications

Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide dinitrate is contraindicated in patients who are allergic to it.

Warnings

Amplification of the vasodilatory effects of dilatrate®-SR by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

The benefits of extended-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of extended-release oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.

Precautions

General

Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide dinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

As tolerance to isosorbide dinitrate develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.

Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the interdosing intervals in some of these trials, anginal attacks have been more easily provoked than before treatment and patients have demonstrated hemodynamic rebound and decreased exercise tolerance. The importance of these observations to the routine, clinical use of controlled-release oral isosorbide dinitrate is not known.

In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers demonstrating the existence of true physical dependence.

Information for patients

Patients should be told that the antianginal efficacy of isosorbide dinitrate is strongly related to its dosing regimen, so the prescribed schedule of dosing should be followed carefully. In particular, daily headaches sometimes accompany treatment with isosorbide dinitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide dinitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide dinitrate-induced headaches with no deleterious effect on isosorbide dinitrate’s antianginal efficacy.

Treatment with isosorbide dinitrate may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Drug interactions

The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of isosorbide dinitrate. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed isosorbide dinitrate at 25 or

100 mg/kg/day.

Pregnancy Category C

At oral doses 35 and 150 times the daily Maximum Recommended Human Dose (MRHD), isosorbide dinitrate has been shown to cause a dose related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women. Isosorbide dinitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known whether isosorbide dinitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide dinitrate is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

Clinical studies of dilatrate®-SR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Adverse reactions to isosorbide dinitrate are generally dose related, and almost all of these reactions are the result of isosorbide dinitrate’s activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE).

Data are not available to allow estimation of the frequency of adverse reactions during treatment with dilatrate®-SR sustained release capsules.

Overdosage

Hemodynamic Effects 

The ill effects of isosorbide dinitrate overdose are generally the results of isosorbide dinitrate’s capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures and death.

Laboratory determinations of serum levels of isosorbide dinitrate and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of isosorbide dinitrate overdose.

There are no data suggesting what dose of isosorbide dinitrate is likely to be life-threatening in humans. In rats, the median acute lethal dose (LD50) was found to be 1100 mg/kg.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide dinitrate and its active metabolites. Similarly, it is not known which, if any, of these substances can usefully be removed from the body by hemodialysis.

No specific antagonist to the vasodilator effects of isosorbide dinitrate is known, and no intervention has been subject to controlled study as a therapy of isosorbide dinitrate overdose. Because the hypotension associated with isosorbide dinitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an increase in central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary. The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.

In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of isosorbide dinitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia

Nitrate ions liberated during metabolism of isosorbide dinitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moieties of isosorbide dinitrate are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of isosorbide dinitrate should be required before any of these patients manifests clinically significant (≥ 10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide dinitrate. In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 4.8-6.9 mg of bioavailable isosorbide dinitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo. Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible. Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial p02. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.

When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1-2 mg/kg intravenously.

Dosage and Administration

As noted above (CLINICAL PHARMACOLOGY), multiple studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for organic nitrates including dilatrate®-SR must provide a daily nitrate-free interval to avoid the development of tolerance. To achieve the necessary nitrate-free interval with immediate-release oral ISDN, it appears that at least one of the daily interdose intervals must be at least 14 hours long. The necessary interdose interval for dilatrate®-SR has not been clearly identified, but it must be greater than 18 hours.

As noted under Clinical Pharmacology, only one trial has ever studied the use of extended-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of dilatrate®-SR was administered twice daily in doses given 6 hours apart. After 4 weeks, dilatrate®-SR could not be distinguished from placebo.

Large controlled studies with other nitrates suggest that no dosing regimen with dilatrate®-SR should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.

In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 to 480 mg.

Do not exceed 160 mg (4 capsules) per day.

How Supplied

dilatrate®-SR (isosorbide dinitrate) 40 mg sustained release capsules are opaque pink and colorless capsules with white beadlets and are imprinted “Schwarz” and “0920”. They are supplied as follows:

Bottles of 100

NDC 0091-0920-01

Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Manufactured for:

By Sandoz Inc.

Princeton, NJ 08540, USA

Dilatrate-SR  isosorbide dinitrate  capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0091-0920 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Isosorbide Dinitrate (Isosorbide Dinitrate) Active 40 MILLIGRAM  In 1 CAPSULE Ethylcellulose Inactive   Lactose Inactive   Pharmaceutical Glaze Inactive   Starch Inactive   Sucrose Inactive   Talc Inactive   D&C Red 33 Inactive   D&C Yellow 10 Inactive   Gelatin Inactive   Titanium Dioxide Inactive

Product Characteristics Color PINK (PINK) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code Schwarz;0920 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0091-0920-01 100 CAPSULE In 1 BOTTLE None

Revised: 01/2008Schwarz Pharma

More Dilatrate-SR resources

• Dilatrate-SR Side Effects (in more detail)
• Dilatrate-SR Dosage
• Dilatrate-SR Use in Pregnancy & Breastfeeding
• Drug Images
• Dilatrate-SR Drug Interactions
• Dilatrate-SR Support Group
• 0 Reviews for Dilatrate-SR - Add your own review/rating

• Dilatrate-SR Concise Consumer Information (Cerner Multum)


• Dilatrate-SR MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilatrate-SR Advanced Consumer (Micromedex) - Includes Dosage Information


• Isosorbide Dinitrate Professional Patient Advice (Wolters Kluwer)


• Isordil Titradose MedFacts Consumer Leaflet (Wolters Kluwer)


• Isosorbide Dinitrate/Mononitrate Monograph (AHFS DI)

Compare Dilatrate-SR with other medications

• Angina
• Angina Pectoris Prophylaxis
• Esophageal Spasm
• Heart Failure
• Pulmonary Arterial Hypertension

Butenafine topical

Generic Name: butenafine topical (byoo TEN ah fine)

Brand names: Mentax, Lotrimin Ultra Athlete's Foot, Lotrimin Ultra Jock Itch

What is butenafine topical?

Butenafine topical is an antifungal medication. Butenafine topical prevents fungus from growing on your skin.

Butenafine topical is used to treat athlete's foot, jock itch, and ringworm.

Butenafine topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about butenafine topical?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use butenafine topical?

Do not use butenafine topical if you have had an allergic reaction to it in the past.

It is not known whether butenafine topical will harm an unborn baby. Do not use butenafine topical without first talking to your doctor if you are pregnant. It is not known whether butenafine passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use butenafine topical?

Use butenafine topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream once daily as directed by your doctor for the specified length of time.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store butenafine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of butenafine topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of butenafine topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that butenafine topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using butenafine topical?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Butenafine topical side effects

Serious side effects of butenafine topical use are not expected. Stop using butenafine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Butenafine topical Dosing Information

Usual Adult Dose for Tinea Pedis:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 4 weeks.

Usual Adult Dose for Tinea Corporis:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 2 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Cruris:

Apply butenafine topical cream in a quantity sufficient to cover the affected area and immediately surrounding skin once daily for 2 weeks, depending on the nature and severity of the infection.

What other drugs will affect butenafine topical?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of butenafine topical

More butenafine topical resources

• Butenafine topical Side Effects (in more detail)
• Butenafine topical Dosage
• Butenafine topical Use in Pregnancy & Breastfeeding
• Butenafine topical Support Group
• 0 Reviews for Butenafine - Add your own review/rating

• Mentax Prescribing Information (FDA)


• Mentax Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Mentax Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare butenafine topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Where can I get more information?

• Your pharmacist has additional information about butenafine topical written for health professionals that you may read.

See also: butenafine side effects (in more detail)

DesOwen Cream Kit Cream

Pronunciation: DES-oh-nide
Generic Name: Desonide
Brand Name: DesOwen Cream Kit

DesOwen Cream Kit Cream is used for:

Relieving inflammation and itching caused by certain skin conditions.

DesOwen Cream Kit Cream is kit that contains a topical corticosteroid and a moisturizing lotion. The corticosteroid reduces skin inflammation. The moisturizing lotion helps to moisturize the skin.

Do NOT use DesOwen Cream Kit Cream if:

• you are allergic to any ingredient in DesOwen Cream Kit Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using DesOwen Cream Kit Cream:

Some medical conditions may interact with DesOwen Cream Kit Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a skin infection, thinning of the skin, tuberculosis (TB), measles, chickenpox, shingles, or a positive TB skin test, or have recently had a vaccination


• if you are taking an oral corticosteroid (eg, prednisone)

Some MEDICINES MAY INTERACT with DesOwen Cream Kit Cream. However, no specific interactions with DesOwen Cream Kit Cream are known at this time.

Ask your health care provider if DesOwen Cream Kit Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use DesOwen Cream Kit Cream:

Use DesOwen Cream Kit Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the corticosteroid cream: Apply a small amount of medicine to the affected area(s) as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• Wash your hands right away after applying DesOwen Cream Kit Cream, unless your hands are part of the treated area.


• Do not cover the treated area(s) with bandages or other dressings unless advised to do so by your health care provider.


• To use the moisturizing lotion: Apply as often as needed to help prevent dry skin.


• If you miss a dose of DesOwen Cream Kit Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use DesOwen Cream Kit Cream.

Important safety information:

• DesOwen Cream Kit Cream is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool tap water.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 2 weeks or if they get worse, check with your doctor.


• Do not apply DesOwen Cream Kit Cream to the groin or diaper area unless your doctor tells you otherwise. If DesOwen Cream Kit Cream is applied to the groin or diaper area, apply a very small amount and do not use tight-fitting undergarments or plastic pants.


• Contact your doctor if you have a cut or sore that does not heal.


• Check with your doctor before you have any vaccines while you are using DesOwen Cream Kit Cream.


• Do not apply DesOwen Cream Kit Cream over large areas of the body without first checking with your doctor.


• Do not use other medicines or products on your skin without first checking with your doctor.


• Overuse of topical products may worsen your condition.


• Do not use DesOwen Cream Kit Cream for other skin conditions at a later time.


• DesOwen Cream Kit Cream is a corticosteroid. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Tell your doctor or dentist that you use DesOwen Cream Kit Cream before you receive any medical or dental care, emergency care, or surgery.


• Serious side effects may occur if too much of DesOwen Cream Kit Cream is absorbed through the skin. This may be more likely to occur if you use DesOwen Cream Kit Cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply DesOwen Cream Kit Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• DesOwen Cream Kit Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks if they use DesOwen Cream Kit Cream.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using DesOwen Cream Kit Cream while you are pregnant. It is not known if DesOwen Cream Kit Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use DesOwen Cream Kit Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of DesOwen Cream Kit Cream:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; mild, temporary stinging or burning.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using DesOwen Cream Kit Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: DesOwen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision or other vision changes; muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual weight gain, especially in the face.

Proper storage of DesOwen Cream Kit Cream:

Store DesOwen Cream Kit Cream at room temperature, between 36 and 86 degrees F (2 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep DesOwen Cream Kit Cream out of the reach of children and away from pets.

General information:

• If you have any questions about DesOwen Cream Kit Cream, please talk with your doctor, pharmacist, or other health care provider.


• DesOwen Cream Kit Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about DesOwen Cream Kit Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More DesOwen Cream Kit resources

• DesOwen Cream Kit Side Effects (in more detail)
• DesOwen Cream Kit Use in Pregnancy & Breastfeeding
• DesOwen Cream Kit Drug Interactions
• DesOwen Cream Kit Support Group
• 5 Reviews for DesOwen - Add your own review/rating

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Dicyclomine Tablets

Generic Name: dicyclomine hydrochloride

Dosage Form: tablet
FULL PRESCRIBING INFORMATION

Indications and Usage for Dicyclomine Tablets

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Dicyclomine Tablets Dosage and Administration

Dosage must be adjusted to individual patient needs.

Oral Dosage and Administration in Adults

The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Dosage Forms and Strengths

• Dicyclomine Hydrochloride 10 mg capsules: dark blue capsules printed "West-ward 3126"


• Dicyclomine Hydrochloride 20 mg tablets: Blue, Round Tablets; Embossed "WW27"

Contraindications

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with:

• unstable cardiovascular status in acute hemorrhage


• myasthenia gravis [see Warnings and Precautions (5.4)]


• glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]


• obstructive uropathy [see Warnings and Precautions (5.8)]


• obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)]


• severe ulcerative colitis [see Warnings and Precautions (5.7)]


• reflux esophagitis

Warnings and Precautions

Cardiovascular Conditions

Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate.  Investigate any tachycardia before administration of dicyclomine hydrochloride.  Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3)].

Peripheral and Central Nervous System

The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system.  They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6)].

In the presence of a high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever.  If symptoms occur, the drug should be discontinued and supportive measures instituted.  Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.  Psychosis has been reported in sensitive individuals given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug

Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine hydrochloride.

Myasthenia Gravis

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).  It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [see Contraindications (4)]

Intestinal Obstruction

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful [see Contraindications (4)].

Rarely development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.

Toxic Dilatation of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

Ulcerative Colitis

Caution should be taken in patients with ulcerative colitis.  Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [see Adverse Reactions (6.3)].  Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [see Contraindications (4)].

Prostatic Hypertrophy

Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [see Adverse Reactions (6.3)]

Hepatic and Renal Disease

Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.

Geriatic Population

Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

Adverse Reactions

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)].  They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system.  These effects are dose-related and are usually reversible when treatment is discontinued. 

The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2,5.3)].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 

The data described below reflect the exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients.  Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. 

Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency

MedDRA Preferred Term	Dicyclomine Hydrochloride  (40 mg four times a day) %	Placebo %
Dry Mouth	33	5
Dizziness	40	5
Vision blurred	27	2
Nausea	14	6
Somnolence	9	1
Asthenia	7	1
Nervousness	6	2

Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group).  In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction.  A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. 

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. 

• Cardiac disorders: palpitations, tachyarrhythmias


• Eye disorders: cycloplegia, mydriasis, vision blurred


• Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting


• General disorders and administration site conditions: fatigue, malaise


• Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock


• Nervous system disorders: dizziness, headache, hallucinations insomnia, somnolence, syncope


• Psychiatric disorders: confusional state, nervousness


• Reproductive system and breast disorders: suppressed lactation


• Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion


• Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Gastrointestinal: anorexia

Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia

Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Ophthalmologic: diplopia, increased ocular tension

Dermatologic/Allergic: urticaria, itching, and other dermal manifestations;

Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy

Cardiovascular: hypertension

Respiratory: apnea

Other: decreased sweating, sneezing, throat congestion, impotence.  

Drug Interactions

Antiglaucoma Agents

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications (4)].

Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity. 

Other Gastrointestinal Motility Drugs

Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.

Effect on Absorption of Other Drugs

Anticholinergic agents may affect the gastrointestinal absorption of various drugs by affecting the gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

Effect on Gastric Acid Secretion

The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.

Reproduction studies have been performed in rats and rabbits at doses of up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Dicyclomine hydrochloride is contraindicated in women who are human milk feeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in human milk-fed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. [see Use in Specific Populations (8.4)].

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age.  [see Contraindications (4)]  There are published cases reporting that the administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

Geriatric Use

Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.  Other reported clinical experience has not identified differences in responses between the elderly and younger patients.  In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride drugs are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.

Hepatic Impairment

Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

Overdosage

In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. 

The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily.) These events resolved after discontinuing the dicyclomine.

The acute oral LD50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [see Warnings and Precautions (5.1)] , the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not known if dicyclomine hydrochloride is dialyzable.

Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

Dicyclomine Tablets Description

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms:

• Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg dicyclomine hydrochloride, USP.  Dicyclomine hydrochloride 10 mg capsules also contain inactive ingredients: Corn Starch, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose. Capsule shells contain FD&C Blue No. 1, FD&C Red No. 4, and Gelatin. The imprinting ink contains Titanium Dioxide.


• Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP.  Dicyclomine hydrochloride 20 mg tablets also contain inactive ingredients: Anhydrous Lactose, FD&C Blue No. 1, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.

Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula:

Molecular weight: 345.95


Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste.  It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. 

Dicyclomine Tablets - Clinical Pharmacology

Mechanism of Action

Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract.  Animal studies indicate that this action is achieved via a dual mechanism:

• A specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and
  


• A direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. 

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2.  Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

Pharmacodynamics

Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

Pharmacokinetics

Absorption and Distribution

In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes.  Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

Elimination

The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).  Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose.  In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. 

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine.  In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition. 

Clinical Studies

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

How Supplied/Storage and Handling

Dicyclomine Hydrochloride Capsules, USP, 10 mg are supplied as dark blue capsules printed "West-ward 3126" and are available in:

Bottles of 100 capsules.

Bottles of 1000 capsules.

Dicyclomine Hydrochloride Tablets, USP 20 mg are supplied as Blue, Round Tablets; Embossed "WW27" and are available in:

Bottles of 100 tablets.

Bottles of 1000 tablets.

Unit Dose Boxes of 100 tablets. 

Patient Counseling Information

Use in Infants

Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations (8.4)] .

Use in Nursing Mothers

Advise lactating women that dicyclomine hydrochloride should not be used while human milk feeding their infants [see Use in Specific Populations (8.3, 8.4)] .

Peripheral and Central Nervous System

In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision.  The patients should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride.  [see Warnings and Precautions (5.3)].

Manufactured By:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724 USA

Revised September 2011

PRINCIPAL DISPLAY PANEL

Dicyclomine Hydrochloride Capsules, USP

10 mg/100 Capsules

NDC 0143-3126-01

PRINCIPAL DISPLAY PANEL

Dicyclomine Hydrochloride Tablets, USP

20 mg/100 Tablets

NDC 0143-1227-01

DICYCLOMINE  dicyclomine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0143-1227 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   FD&C BLUE NO. 1   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color BLUE (BLUE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code WW;27 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0143-1227-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0143-1227-10 1000 TABLET In 1 BOTTLE, PLASTIC None 3 0143-1227-25 100 TABLET In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040161	10/01/1996

Labeler - West-ward Pharmaceutical Corp (001230762)

Establishment
Name	Address	ID/FEI	Operations
West-ward Pharmaceutical Corp		001230762	MANUFACTURE

Revised: 10/2011West-ward Pharmaceutical Corp

More Dicyclomine Tablets resources

• Dicyclomine Tablets Side Effects (in more detail)
• Dicyclomine Tablets Dosage
• Dicyclomine Tablets Use in Pregnancy & Breastfeeding
• Drug Images
• Dicyclomine Tablets Drug Interactions
• Dicyclomine Tablets Support Group
• 23 Reviews for Dicyclomines - Add your own review/rating

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Bontril Slow-Release Capsules

phendimetrazine tartrate

Dosage Form: capsule
BONTRIL®

SLOW RELEASE

BRAND OF

PHENDIMETRAZINE TARTRATE

SLOW-RELEASE CAPSULES

105 mg

CIII

Rx Only

Bontril Slow-Release Capsules Description

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (+)-3,4-Dimethyl-2-phenylmorpholine Tartrate.

The structural formula is as follows:

C12H17NO•C4H6O6                    M.W. 341.36

Phendimetrazine tartrate is a white, odorless powder with a bitter taste. It is soluble in water, methanol and ethanol.

Bontril® Slow-Release capsules contain FD&C Yellow No. 6 as a color additive.

Bontril Slow-Release Capsules - Clinical Pharmacology

Phendimetrazine tartrate is a sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects may be involved.

Adult obese subjects instructed in dietary management and treated with anorectic drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origin of the increased weight loss due to the various drug effects is not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The active drug 105 mg of phendimetrazine tartrate in each capsule of this special slow-release dosage form approximates the action of three 35 mg non-time release doses taken at 4 hour intervals.

The major route of elimination is via the kidneys where most of the drug and metabolites are excreted. Some of the drug is metabolized to phenmetrazine and also phendimetrazine-N-oxide.

The average half-life of elimination when studied under controlled conditions is about 1.9 hours for the non-time and 9.8 hours for the slow-release dosage form. The absorption half-life of the drug from conventional non-time 35 mg phendimetrazine tablets is approximately the same. These data indicate that the slow-release product has a similar onset of action to the conventional non-time-release product and, in addition, has a prolonged therapeutic effect.

INDICATIONS

Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see ACTIONS) should be measured against possible risk factors inherent in their use such as those described below.

Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. Use in patients taking other CNS stimulants including monoamine oxidase inhibitors.

Warnings

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Use of phendimetrazine within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Precautions

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen.

Phendimetrazine may decrease the hypotensive effect of guanethidine.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Usage in Pregnancy

Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Usage in Children

Phendimetrazine tartrate is not recommended for use in children under 12 years of age.

Adverse Reactions

Cardiovascular: Palpitation, tachycardia, elevation of blood pressure.

Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, tremor, headache; rarely psychotic episodes at recommended doses, agitation, flushing, sweating, blurring of vision.

Gastrointestinal: Dryness of the mouth, diarrhea, constipation, nausea, stomach pain.

Genitourinary: Changes in libido, urinary frequency, dysuria.

Drug Abuse and Dependence

Controlled Substance

Phendimetrazine is a Schedule lll controlled substance.

Dependence

Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

Manifestations of acute overdosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death.

Management of acute intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard.

Acidification of the urine increases phendimetrazine tartrate excretion.

Intravenous phentolamine (Regitine) has been suggested for possible acute, severe hypertension, if this complicates overdosage.

Bontril Slow-Release Capsules Dosage and Administration

One Slow-Release Capsule (105 mg) in the morning, taken 30-60 minutes before the morning meal.

Phendimetrazine Tartrate is not recommended for use in children under twelve years of age.

How is Bontril Slow-Release Capsules Supplied

Bontril Slow Release Capsules (phendimetrazine tartrate 105 mg) is available as opaque green and clear yellow capsules, imprinted with "VALEANT" and "BONTRIL 105". Phendimetrazine Slow-Release Capsules are available in bottles of 100 (NDC #0187-0498-01) and 1000 (NDC 0187-0498-02).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Distributed by:

Valeant Pharmaceuticals North America

One Enterprise

Aliso Viejo, CA 92656 USA

Manufactured by:

Mallinckrodt Inc.

Hobart, NY 13788

Printed with food grade ink.

MG #20887

Rev. 3/07

Part No. L2BB02

PRINCIPAL DISPLAY PANEL - 105 mg Bottle Label

NDC 0187-0498-01

Rx Only

Bontril®

SLOW-

RELEASE

(phendimetrazine tartrate)

CIII

Each slow-

release capsule

contains 105 mg

phendimetrazine

tartrate

105 mg

100

Capsules

VALEANT™

BONTRIL  phendimetrazine tartrate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0187-0498 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phendimetrazine Tartrate (Phendimetrazine) Phendimetrazine Tartrate 105 mg

Inactive Ingredients Ingredient Name Strength FD&C Yellow No. 6

Product Characteristics Color GREEN (green) , YELLOW (yellow) Score no score Shape CAPSULE (Capsule) Size 20mm Flavor Imprint Code VALEANT;BONTRIL;105 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0187-0498-01 100 CAPSULE In 1 BOTTLE None 2 0187-0498-02 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088021	09/21/1982

Labeler - Valeant Pharmaceuticals International (042230623)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt		957414238	MANUFACTURE

Revised: 02/2011Valeant Pharmaceuticals International

More Bontril Slow-Release Capsules resources

• Bontril Slow-Release Capsules Side Effects (in more detail)
• Bontril Slow-Release Capsules Dosage
• Bontril Slow-Release Capsules Use in Pregnancy & Breastfeeding
• Drug Images
• Bontril Slow-Release Capsules Drug Interactions
• Bontril Slow-Release Capsules Support Group
• 24 Reviews for Bontril Slow-Release - Add your own review/rating

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